Delayed Post-Polypectomy Induced Ulcer Hemorrhage Clinical Trial
Official title:
Blood Flow Monitoring to Prevent Post-Polypectomy Induced Ulcer Bleeding.
The primary specific aim is to perform a randomized controlled trial (RCT) to compare rates of delayed hemorrhage after DEP detection of arterial blood flow and focal treatment in PPIU's (treatment arm) with standard treatment using medical guidelines alone (controls) for prevention of delayed bleeding in high risk patients (on anti-coagulants or anti-platelet drugs or with large ulcers) after snare resection of benign colon polyps.
VA Central Office recently opened back research study after suspension from March to Sept 2020 with COVID 19 Severe delayed post-polypectomy induced ulcer (PPIU) bleeding has become a much more common problem with the increased numbers of colonoscopies being performed and with more patients taking anti-coagulants or anti-platelet drugs. Current medical guidelines may reduce bleeding during polypectomy, but are not effective for prevention of delayed bleeding. Empiric closure of PPIU's with clips is not effective because ulcers > 15 mm cannot be closed, does not treat the underlying artery in the ulcer base, and when the clips often fall off within 7 the underlying artery is exposed. As preliminary results, the investigators studied delayed PPIU bleeds and their prevention, used a Doppler endoscopic probe (DEP) to localize arteries in PPIU's, reported the prevalence which rises significantly as ulcer size increases, and successfully obliterated blood flow with focal treatment. These studies form the basis for this new RCT. The primary specific aim is to perform a RCT to compare rates of delayed hemorrhage after DEP detection of arterial blood flow and focal treatment in PPIU's (treatment arm) with standard treatment using medical guidelines alone (controls) for prevention of delayed bleeding in high risk patients (on anti-coagulants or anti-platelet drugs or with large ulcers) after snare resection of benign colon polyps. Secondary specific aims are to evaluate the natural history and risk factors for delayed PPIU bleeding using univariate and multivariable analyses. This is a RCT performed by the CURE Hemostasis Research Group for high risk patients - those with PPIU's 15 mm in size or greater but not on drugs associated with bleeding; or patients who require anti-coagulants or anti-platelet drugs for treatment of co-morbid conditions and have PPIU's 10 mm or larger. Outpatients, scheduled for screening or surveillance colonoscopies, who give written informed consent and meet entry criteria will be randomized to control/no DEP (medical treatment without PPIU closure) or DEP (as a guide to arterial blood flow detection and focal obliteration of it with hemoclips and/or low power multipolar electrocautery [MPEC] probe). Patients will be prospectively followed at 7, 14, and 30 days for bleeding, complications, or unscheduled visits for healthcare after polypectomies. ;